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FDA Offers Make-Believe Solution to Antibiotic Resistance

Instead of taking real action to limit the use of antibiotics in healthy livestock, FDA today announced a final version of their list of recommendations – called a “guidance” – for the livestock industry. (They also put out a draft guidance document with recommendations and guidelines for further voluntary action by industry and a draft proposed rule meant to facilitate such voluntary action.) FDA doesn't actually require the livestock industry to do anything to stop endangering human health. This is an ineffective response to the alarming rise in antibiotic resistance, which threatens human health. The FDA is taking no effective action even as it acknowledges that use of antibiotics in livestock is a (growing) problem.

FDA is going ahead with this empty gesture even though a federal court recently ruled that providing guidance is not sufficient to meet FDA’s obligation to regulate the use of certain antibiotics—penicillin and tetracyclines—in animal feed because FDA has already found that the use of those antibiotics in animal feed may pose a risk to human health by promoting antibiotic resistance. Therefore, the agency must withdraw approval for these antibiotic uses unless drug manufacturers prove in an administrative hearing that the uses are safe. The guidance does not meet FDA’s legal obligation. To top it off, final guidance is no more binding than the draft one. The added value is exceedingly small.

Public health authorities in the US and around the world agree that the overuse of vast quantities of antibiotics on livestock to hasten weight gain and compensate for crowded, filthy conditions is contributing to a crisis of antibiotic resistance in human medicine. Antibiotic resistance is reducing the effectiveness of common, widely used antibiotics--leading to longer and more severe illnesses, the need to use antibiotics with greater side-effects, and in some cases, lives lost as treatments fail.

FDA’s guidance will not help solve the problem because the guidance has no binding force: it is still entirely up to the livestock industry to decide whether to follow the recommendations or ignore them. And even if we hear encouraging promises from industry, there is no assurance that improvements will actually follow. In fact, based on what we have seen so far we fully expect that non-binding guidance will do nothing to change the overuse of antibiotics in healthy livestock. Why is that? We have essentially been using a system of voluntary action since public health risks were revealed over three decades ago. Also, the guidance has existed in draft form since 2010. There is no reason to expect different results from more of the same.

Pharmaceutical companies have a vested interest in continuing to sell antibiotics – 80% of antibiotics in the U.S. are used for livestock. Livestock producers also have a vested interest in continuing their existing practices and fattening up their animals faster. Even if a couple of actors make the right moves out of the goodness of their hearts, that won’t ensure change in the whole industry, which is the level at which change is required. FDA has a legal duty to protect public health and to determine if drugs have not been shown to be safe, and if so, to withdraw approval for their use.

NRDC and its partners have been litigating to compel the FDA to act on its statutory obligations, and FDA has repeatedly trotted out its non-binding voluntary guidance as evidence of its ‘action’ on the issue. But this is the opposite of action. Not only is this not what the law requires of FDA, it does nothing to ensure that antibiotic use in livestock is actually reduced to slow the rise of antibiotic resistance.

FDA’s mandate is to protect our food, our health and our families. That requires them to heed the science, stand up to those who work to obfuscate it, and protect our health. Last week they failed to do so denying our petition to remove BPA from food. This week, the agency is blithely continuing its policy of letting the livestock industry police itself. What is going on here?

This guidance does not satisfy FDA’s duties: the problem of antibiotic resistance is all too real, unlike FDA’s make-believe solution. Instead, FDA should move expeditiously to act on the court’s decision.